ProSomnus gets FDA nod for latest sleep apnea therapy device
April 13, 2026
ProSomnus announced today that it received FDA 510(k) clearance for its RPMO₂ obstructive sleep apnea (OSA) therapy device.
ProSomnus announced today that it received FDA 510(k) clearance for its RPMO₂ obstructive sleep apnea (OSA) therapy device.
Used with Beckman’s immunoassay analysers, MeMed’s BV test has been demonstrated to reduce unnecessary antibiotic use.
Blood- and bone marrow-based efficient growth factors extraction system demonstrates substantial equivalence and high cell viability
Modular Medical (Nasdaq:MODD) announced today that it received FDA 510(k) clearance for its next-generation insulin patch pump.
CorTec’s BCI aims to differentiate itself by offering brain-based communication alongside therapeutic neurostimulation.
Sibel Health today announced FDA 510(k) clearance of ANNE® Maternal, the world’s first fully wireless, comprehensive maternal-fetal monitoring platform.
DALLAS, April 8, 2026 /PRNewswire/ — Dallas-based MedCAD has received FDA 510(k) clearance of its AccuStride® lower leg tibia and fibula system, making these patient-specific precision devices available to surgeons. The unique design of the custom-made planning and surgical guides will enable orthopedic surgeons to correct multiple related pathologies and osteotomies in a single procedure.
Research suggests that over 120,000 patients suffer from aortic arch disease in the US and Europe annually, but only around 25% of patients are diagnosed or treated.
Adagio Medical (Nasdaq:ADGM) announced today that it received FDA investigational device exemption (IDE) to expand its FULCRUM-VT trial.
BD (NYSE:BDX) announced today that it received CE mark approval for its Liverty TIPS stent graft system.